Efficacy of Montelukast in Preventing Transaminase Elevation in Adult Dengue Patients

NCT06747130 | Recruiting Phase 2 DMC

• 1 other identifier: R165h/67
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if drug montelukast works to treat dengue in adults. It will also learn about the safety of drug montelukast . The main questions it aims to answer are: Does drug montelukast lower the incidence of liver enzyme elevations in participants ? What medical problems do participants have when taking drug montelukast ?

Conditions

Dengue; Montelukast; Transaminases

Outcome Measures

Primary Outcomes (1)

• Serum transaminase levels on the recovery day

  Serum alanine transaminase and aspartate transaminase level will be measured at admission, and on every morning afterwards until the subject is discharged. The proportion of subjects with abnormal serum transaminase levels will be compared. The recovery day is defined as the day the participant was discharged from the hospital.

  From enrollment to the end of treatment at 10 days

Secondary Outcomes (7)

• Proportion of subjects with abnormal serum transaminase levels on the recovery day

  From enrollment to the end of treatment at 10 days

• Length of stay

  From enrollment to the end of treatment at 10 days

• Changes in serum transaminase levels

  From enrollment to the end of treatment at 10 days

• Rate of dengue with warning signs

  From enrollment to the end of treatment at 10 days

• Rate of severe dengue

  From enrollment to the end of treatment at 10 days

Study Arms (2)

Montelukast

EXPERIMENTAL

a 10 mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

a 10 mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Drug: Montelukast Placebo

Interventions

Montelukast DRUG

A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Montelukast

Montelukast Placebo DRUG

A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age \>18 years
• Dengue infection diagnosed by NS1 antigen, or polymerase chain reaction
• Admitted to the hospital
• Written informed consent from patient or attending relative able to and willing to give informed consent

You may not qualify if:

• Other possible cause of fever other than dengue infection
• Pregnancy
• Unable to take medication
• Aminotransferase level above 150 U/l
• Allergy to paracetamol or tramadol
• Paracetamol indicated for condition other than dengue infection
• Critically ill patient who need ICU or invasive ventilation support
• History of cirrhosis
• Unable to communicate
• Other indication of montelukast
• History of psychiatric illness

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramongkutklao Hospital

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Dengue

Interventions

montelukast

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Worapong Nasomsong, MD

  Phramongkutklao College of Medicine and Hospital

  STUDY DIRECTOR

Central Study Contacts

Vasin Vasikasin, MD PhD

CONTACT

66+027639300; vvasin@gmail.com

Kotchaphon Waithayakul, MD

CONTACT

66+027639300; nasomsong.w@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Consultant in Infectious Disease

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

TH (1)